|Publication number||US7930027 B2|
|Application number||US 11/742,085|
|Publication date||Apr 19, 2011|
|Filing date||Apr 30, 2007|
|Priority date||Apr 30, 2007|
|Also published as||EP2142250A1, EP2142250B1, US20080269816, US20110196444, WO2008134636A1|
|Publication number||11742085, 742085, US 7930027 B2, US 7930027B2, US-B2-7930027, US7930027 B2, US7930027B2|
|Inventors||Rajan Prakash, Aleksandre T. Sambelashvili|
|Original Assignee||Medtronic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (24), Non-Patent Citations (3), Referenced by (7), Classifications (14), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Cardiac resynchronization therapy (CRT) is an effective treatment for heart failure patients. One goal of CRT is the production of a mechanically synchronous ventricular contraction.
Studies demonstrate that CRT therapy which provides pacing only to the left ventricle (LV only pacing) produces hemodynamic benefits similar to bi-ventricular pacing. LV only pacing algorithms attempt to achieve electrical fusion by timing the left ventricular pulse (LV pace) based upon sensed electrical signals such as right ventricular intrinsic depolarization. The underlying assumption of such algorithms is that artificial coupling of the LV stimulus and the intrinsic RV depolarization will result in a mechanically synchronous contraction. However, the timing of electrical events may not correlate well with the timing of mechanical events. For example, some forms of CRT attempt to deliver the LV pacing stimulus in such a way that it precedes the RV sensed electrical event by a pre-defined time interval. However, the RV sensed event corresponds to the instant of local electrical activation under the tip of the RV electrode and may not reflect the global ventricular excitation pattern. In addition, there may be variations in conduction velocities or in excitation-contraction coupling among the heart tissues at different locations in the heart. Therefore, timing delivery of a left ventricular pulse based upon measured electrical events such as the RV sensed event may not result in a mechanically synchronous contraction. Therefore, in order to achieve a mechanically fused left ventricular contraction, it is desirable to provide left ventricular stimulation based on the mechanical activity of the heart, sensed using implanted sensors, rather than the electrical activity.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings depict selected embodiments and are not intended to limit the scope of the invention. It will be understood that embodiments shown in the drawings and described below are merely for illustrative purposes, and are not intended to limit the scope of the invention as defined in the claims.
Information from mechanical sensors may be used to time delivery of an LV pacing pulse (LV pace) to achieve a mechanically fused left ventricular contraction. For example, delivery of the LV pace may be timed to specific events associated with cardiac mechanical activity. Mechanical fusion may occur when mechanical response intervals such as the interventricular delay (IV delay) and the pre-ejection interval (PEI) are preset or modified to desired values. The timing of the LV pace (AV interval) may be adjusted until the Vpace results in the mechanical response interval being equal to the desired value, indicating that mechanical fusion is occurring.
Implantable medical devices (IMDs) useful for this invention include devices which provide cardiac resynchronization therapy and cardiac potentiation therapy as well as other cardiac stimulation devices.
Three endocardial leads 16, 32 and 52 connect the IMD 14 with the RA, the RV and the LV, respectively. Each lead has at least one electrical conductor and pace/sense electrode, and a can electrode 20 may be formed as part of the outer surface of the housing of the IMD 14. The pace/sense electrodes and can electrode 20 may be selectively employed to provide a number of unipolar and bipolar pace/sense electrode combinations for pacing and sensing functions. The depicted positions in or about the right and left heart chambers are merely exemplary. Moreover other leads and pace/sense electrodes may be used instead of the depicted leads and pace/sense electrodes.
It should be noted that the IMD 14 may also be an implantable cardioverter defibrillator (ICD), a cardiac resynchronization therapy (CRT) device, an implantable hemodynamic monitor (IHM), or any other such device or combination of devices, according to various embodiments of the invention.
Typically, in pacing systems of the type illustrated in
In addition, some or all of the leads shown in
Accelerometer 62 may be embodied as a uniaxial, biaxial, or triaxial (or multiaxial) accelerometer contained in a capsule of a relatively small size and diameter such that it may be included in a coronary sinus lead without substantially increasing the lead diameter or impairing the ability to steer the lead to a left ventricular stimulation and sensing site. Accelerometer 62 may alternatively be provided as another type of transducer such as a transducer having an optical, acoustical, piezoelectric, inductive, capacitive, resistive, or other elements which produce a variable signal proportional to ventricular acceleration or from which variations in ventricular acceleration can be derived. The accelerometer 62 may be of any suitable type including primary transducers such as spring-retained seismic mass, and secondary transducers, such as piezoelectric, potentiometric, servo, strain gauge, capacitive and vibrating element.
Accelerometer 62 may be located on a lead 52 in the coronary sinus such that when lead 52 is positioned for LV stimulation and sensing, accelerometer 62 is located over the left ventricle, such as over the left ventricular free wall mid-lateral to mid-basal segments. The depicted positions of the leads and electrodes shown in
Epicardial lead 64 may be provided with a fixation member 63 which may serve additionally as a pacing and/or sensing electrode. In some cases, an epicardial lead may be preferred over a coronary sinus lead due to the difficulty of advancing a coronary sinus lead into a relatively small cardiac vein over the LV free wall. Placement of a coronary sinus lead can be a cumbersome task due to the tortuosity of the cardiac veins. Therefore, it may be desirable, at least in some patients, to provide an epicardial lead that can be positioned on the LV lateral wall for stimulation, EGM sensing and acceleration sensing, thereby eliminating the need for a coronary sinus lead. Alternatively, it may be desirable to deploy a small diameter coronary sinus lead for LV stimulation and EGM sensing with a separate LV epicardial lead positioned for sensing LV acceleration.
The leads and circuitry described above can be employed to record EGM signals, blood pressure signals, acceleration, impedance values over certain time intervals and other sensor data. The recorded data may be periodically telemetered out to a programmer operated by a physician or other healthcare worker in an uplink telemetry transmission during a telemetry session, for example.
The therapy delivery system 106 can be configured to include circuitry for delivering cardioversion/defibrillation shocks and/or cardiac pacing pulses delivered to the heart or cardiomyostimulation to a skeletal muscle wrapped about the heart. Alternately, the therapy delivery system 106 can be configured as a drug pump for delivering drugs into the heart to alleviate heart failure or to operate an implantable heart assist device or pump implanted in patients awaiting a heart transplant operation.
The input signal processing circuit 108 includes at least one physiologic sensor signal processing channel for sensing, amplifying, filtering, averaging, digitizing or otherwise processing a sensor derived signal from a physiologic sensor located in relation to a heart chamber or elsewhere in the body. Examples illustrated in
The pair of pace/sense electrodes 140, 142 are located in operative relation to the heart 10 and coupled through lead conductors 144 and 146, respectively, to the inputs of a sense amplifier 148 located within the input signal processing circuit 108. The sense amplifier 148 is selectively enabled by the presence of a sense enable signal that is provided by control and timing system 102. The sense amplifier 148 is enabled during prescribed times when pacing is either enabled or not enabled in a manner known in the pacing art. The blanking signal is provided by control and timing system 102 upon delivery of a pacing or PESP pulse or pulse train to disconnect the sense amplifier inputs from the lead conductors 144 and 146 for a short blanking period in a manner well known in the art. The sense amplifier provides a sense event signal signifying the contraction of the heart chamber commencing a heart cycle based upon characteristics of the EGM. The control and timing system responds to non-refractory sense events by restarting an escape interval (EI) timer timing out the EI for the heart chamber, in a manner well known in the pacing art.
The pressure sensor 160 is coupled to a pressure sensor power supply and signal processor 162 within the input signal processing circuit 108 through a set of lead conductors 164. Lead conductors 164 convey power to the pressure sensor 160, and convey sampled blood pressure signals from the pressure sensor 160 to the pressure sensor power supply and signal processor 162. The pressure sensor power supply and signal processor 162 samples the blood pressure impinging upon a transducer surface of the sensor 160 located within the heart chamber when enabled by a pressure sense enable signal from the control and timing system 102. Absolute pressure (P), developed pressure (DP) and pressure rate of change (dP/dt) sample values can be developed by the pressure sensor power supply and signal processor 162 or by the control and timing system 102 for storage and processing.
A variety of hemodynamic parameters may be recorded including, for example, right ventricular (RV) systolic and diastolic pressures (RVSP and RVDP), left ventricular (LV) systolic and diastolic pressures (LVSP and LVDP), estimated pulmonary artery diastolic pressure (ePAD), pressure changes with respect to time (dP/dt), heart rate, activity, and temperature. Some parameters may be derived from others, rather than being directly measured. For example, the ePAD parameter may be derived from RV pressures at the moment of pulmonary valve opening, and heart rate may be derived from information in an intracardiac electrogram (EGM) recording.
The set of impedance electrodes 170, 172, 174 and 176 is coupled by a set of conductors 178 and is formed as a lead that is coupled to the impedance power supply and signal processor 180. Impedance-based measurements of cardiac parameters such as stroke volume are known in the art, such as an impedance lead having plural pairs of spaced surface electrodes located within the heart 10. The spaced apart electrodes can also be disposed along impedance leads lodged in cardiac vessels, e.g., the coronary sinus and great vein or attached to the epicardium around the heart chamber. The impedance lead may be combined with the pace/sense, pressure sensor and/or accelerometer bearing lead.
The data stored by IMD 14 may include continuous monitoring of various parameters, for example recording intracardiac EGM data at sampling rates as fast as 256 Hz or faster. In certain embodiments of the invention, an IHM may alternately store summary forms of data that may allow storage of data representing longer periods of time. In one embodiment, hemodynamic pressure parameters may be summarized by storing a number of representative values that describe the hemodynamic parameter over a given storage interval. The mean, median, an upper percentile, and a lower percentile are examples of representative values that may be stored by an IHM to summarize data over an interval of time (e.g., the storage interval). In one embodiment of the invention, a storage interval may contain six minutes of data in a data buffer, which may be summarized by storing a median value, a 94th percentile value (i.e., the upper percentile), and a 6th percentile value (i.e., the lower percentile) for each hemodynamic pressure parameter being monitored. In this manner, the memory of the IHM may be able to provide weekly or monthly (or longer) views of the data stored. The data buffer, for example, may acquire data sampled at a 256 Hz sampling rate over a 6 minute storage interval, and the data buffer may be cleared out after the median, upper percentile, and lower percentile values during that 6 minute period are stored. It should be noted that certain parameters measured by the IHM may be summarized by storing fewer values, for example storing only a mean or median value of such parameters as heart rate, activity level, and temperature, according to certain embodiments of the invention.
Hemodynamic parameters that may be monitored in accordance with various embodiments of the invention include parameters that are directly measured, such as LV lateral wall acceleration, septal acceleration, RVDP and RVSP. Other parameters may be derived from these parameters, such as estimated pulmonary artery diastolic pressure (ePAD) and the rate of change of pressure (dP/dt).
The amount of improvement in cardiac function resulting from CRT in patients with LBBB depends upon the timing of the delivery of the left ventricular pacing stimulus. When the timing of the pace is adjusted such that the intrinsic activation wavefront fuses with the wavefront from LV pacing site, fusion pacing occurs. Fusion pacing is believed to produce significant improvement in left ventricular function. Therefore, some embodiments of the invention time the delivery of the left ventricular pacing stimulus to produce fusion therapy.
In LV only pacing, the excitation or stimulus originating in the right atrium conducts naturally to the right ventricle to cause right ventricular contraction while the left ventricle is stimulated to contract by the IMD. Therefore the timing of the left ventricular contraction may be moved earlier or later, resulting in shortened or lengthened mechanical response intervals such as interventricular (IV) delay and pre-ejection interval (PEI). By adjusting the timing of LV pace, a desired mechanical response interval may be achieved.
The desired IV delay and PEI may be determined by study, such as by use of an echocardiogram. Alternatively, a value of the IV delay or PEI which is known to provide fusion therapy, for example based on known or published values, may be selected as the desired IV delay or PEI. In some embodiments, the IMD may determine the desired IV delay or PEI for an individual patient. For example, the IMD may measure the IV delay or PEI at a long and at a short AV interval (that is, with the LV pace either late or no pace and LV pace early). When the AV interval is long, such as with either a late LV pace or no pacing, the LV contraction is due to intrinsic conduction rather than the LV pace stimulus. When the AV interval is short, the LV contraction is due to the paced stimulus without intrinsic conduction. However, the preferred AV interval is in between these long and short AV intervals, allowing for fusion of the paced stimulus with intrinsic conduction. The IMD may calculate a preferred IV delay by adding the IV delay measured at a long AV interval and the IV delay measured at a short AV interval. The sum of the IV delays is then divided by two to determine the desired IV delay. The IMD may perform the same calculation to determine the desired PEI. Thus the PEI measured at a long AV interval may be added to the PEI measured at a short AV interval and this sum may be divided by two to determine the desired PEI.
Certain embodiments of the invention monitor mechanical signals such as accelerometer and pressure signals to identify particular cardiac events. For example, an accelerometer may be located in any portion of the heart to detect mechanical activity of that portion of the heart. The accelerometer shows a repeating pattern of activity reflecting the motion of the portion of the heart to which it is attached. An LV accelerometer may be used to detect mechanical activity in the left ventricle, allowing the detection of various components of the cardiac cycle such as aortic valve opening 202 and pulmonic valve closing 204, as shown in
The IMD may detect aortic valve opening 202 and/or aortic valve closing 206 by processing a signal from an LV accelerometer. The first predominant peak during isovolumic contraction in an LV accelerometer signal occurs close to the S1 heart sound and may be identified as corresponding to aortic valve opening 202. For example, the point of maximum ventricular acceleration may be identified as the aortic valve opening 202, as shown in
The predominant peak post ejection in the LV accelerometer signal occurs close to S2 heart sound and may be identified as the aortic valve closure 206. In some embodiments, a detection window may be used for detection of aortic valve closure. For example, the window may begin at about 250 milliseconds after R wave detection and end at about 400 milliseconds after R-wave detection. Other methods of defining the window may also be used. During the window, aortic valve closure 206 may be identified as the point of maximum rate of change (the maximum derivative) of the LV accelerometer signal. Alternatively, the point where the accelerometer signal crosses a particular threshold value such as zero, or mean or median acceleration over a cardiac cycle during the time window may be identified as the aortic valve closure 206.
Different methods may be employed to identify a point on an accelerometer reading as corresponding to a particular mechanical event. The methods of identifying a particular mechanical event using an accelerometer may not all identify precisely the same point in time. However, it is expected that the methods will identify points in time which are close, if not identical, to each other and therefore are sufficiently correlated with the mechanical event to represent the occurrence of the mechanical event. In addition, because of the repeating pattern of the accelerometer with each cardiac cycle, the same point in time can be identified precisely with each cycle, regardless of what method of identification is used. Furthermore, while various methods of identification may identify slightly different moments in time, it is believed that such methods are more likely to be closely correlated to the mechanical event than electrical based methods of identification of mechanical events.
Mechanical events in the right ventricle may be identified by the IMD using an RV accelerometer signal in the manner described above, such as by detecting the peak RV acceleration or maximum derivative of RV acceleration during a time window. Alternatively, mechanical events in the right ventricle may be identified using a pressure sensor. For example, as shown in
In some embodiments, the IMD includes an LV accelerometer and an RV pressure sensor. The IMD of such embodiments may vary the timing of the LV pace in order to produce a desired IV delay. An example of this optimization process is shown in
As shown in the process outlined in
In some embodiments, the IMD may monitor the signal from only a single mechanical sensor as part of the LV pacing optimization process. For example, the IMD may include an LV accelerometer and may perform the process presented in
Some embodiments of the invention optimize pacing to produce synchrony within a ventricle, or intraventricular synchrony. Such embodiments may employ mechanical sensors which detect mechanical activity at least two locations within one ventricle. For example, the IMD may include an LV accelerometer on a lateral wall of the left ventricle. It may also include an accelerometer on the septum, such as an accelerometer located in the right ventricle on the septal wall, to detect septal wall motion. An IMD with an LV lateral wall accelerometer and septal accelerometer may optimize intraventricular synchrony.
In some embodiments, the IMD may allow for both intrinsic and paced right atrial stimulation. When the atrium is paced, the conduction time to ventricles will be slower than with an intrinsic or sensed beat. This time difference, known as the paced-sensed offset, may be calculated by the IMD. With each beat, the IMD then determines whether an sensed or paced RA stimulus has occurred, and adjusts the AV interval (the timing of the LV pace) appropriately.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4719921||Aug 28, 1985||Jan 19, 1988||Raul Chirife||Cardiac pacemaker adaptive to physiological requirements|
|US5168869||Jun 17, 1991||Dec 8, 1992||Raul Chirife||Rate responsive pacemaker controlled by isovolumic contraction time|
|US5334222||Nov 3, 1992||Aug 2, 1994||Cardiac Pacemakers, Inc.||Cardiac stimulating apparatus and method for heart failure therapy|
|US5540727||Nov 15, 1994||Jul 30, 1996||Cardiac Pacemakers, Inc.||Method and apparatus to automatically optimize the pacing mode and pacing cycle parameters of a dual chamber pacemaker|
|US5549650 *||Jun 13, 1994||Aug 27, 1996||Pacesetter, Inc.||System and method for providing hemodynamically optimal pacing therapy|
|US5626623||Apr 30, 1996||May 6, 1997||Medtronic, Inc.||Method and apparatus for optimizing pacemaker AV delay|
|US5836987 *||Mar 12, 1997||Nov 17, 1998||Cardiac Pacemakers, Inc.||Apparatus and method for optimizing cardiac performance by determining the optimal timing interval from an accelerometer signal|
|US6144880||May 8, 1998||Nov 7, 2000||Cardiac Pacemakers, Inc.||Cardiac pacing using adjustable atrio-ventricular delays|
|US6832112||Dec 28, 2001||Dec 14, 2004||Pacesetter, Inc.||Method of adjusting an AV and/or PV delay to improve hemodynamics and corresponding implantable stimulation device|
|US6871088||Mar 20, 2003||Mar 22, 2005||Medtronic, Inc.||Method and apparatus for optimizing cardiac resynchronization therapy|
|US6871096||Oct 26, 2001||Mar 22, 2005||Medtronic, Inc.||System and method for bi-ventricular fusion pacing|
|US6885889||Feb 28, 2003||Apr 26, 2005||Medtronic, Inc.||Method and apparatus for optimizing cardiac resynchronization therapy based on left ventricular acceleration|
|US7092759||Jul 30, 2003||Aug 15, 2006||Medtronic, Inc.||Method of optimizing cardiac resynchronization therapy using sensor signals of septal wall motion|
|US7269460||Feb 28, 2003||Sep 11, 2007||Medtronic, Inc.||Method and apparatus for evaluating and optimizing ventricular synchronization|
|US7548784||Mar 22, 2005||Jun 16, 2009||Medtronic, Inc.||Method and apparatus for optimizing cardiac resynchronization therapy|
|US20010012953||Dec 18, 2000||Aug 9, 2001||Molin Renzo Dal||Active implantable medical device, in particular a pacemaker, defibrillator and/or cardiovertor of the multisite type providing resynchronization of the ventricles|
|US20040019365||Jul 26, 2002||Jan 29, 2004||Jiang Ding||Method and apparatus for optimizing cardiac pumping performance|
|US20040215252||Apr 25, 2003||Oct 28, 2004||Alexander Adrianus Martinus Verbeek||Cardiac pacing for optimal intra-left ventricular resynchronization|
|US20050203579||Mar 12, 2004||Sep 15, 2005||Sameh Sowelam||Real-time optimization of right to left ventricular timing sequence in bi-ventircular pacing of heart failure patients|
|US20050209648||Mar 17, 2004||Sep 22, 2005||Burnes John E||Apparatus and methods of energy efficient, atrial-based Bi-ventricular fusion-pacing|
|US20050209649||Mar 17, 2004||Sep 22, 2005||Bozidar Ferek-Petric||Mechanical sensing system for cardiac pacing and/or for cardiac resynchronization therapy|
|US20050209650||Mar 17, 2004||Sep 22, 2005||Van Gelder L M||Apparatus and method for "LEPARS" interval-based fusion pacing|
|US20070083243||Oct 7, 2005||Apr 12, 2007||Rajan Prakash||Method and apparatus for monitoring and optimizing atrial function|
|WO2007090003A1||Jan 22, 2007||Aug 9, 2007||Medtronic Inc||Method and apparatus for determining optimal pacing therapy timing intervals|
|1||International Search Report, PCT/US2008/061773, May 8, 2008, 6 Pages.|
|2||Leciercq, et al. Systolic Improvement and Mechanical Resynchronization Does Not Require Electrical Synchrony in the Dilated Failing Heart with Left Bundle-Branch Block. Circulation 1761-1763. Oct. 1, 2002.|
|3||Verbeek, et al. Talloring Cardiac Resynchronization Therapy using Interventricular Asynchrony. Validation of a Simple Model. AJP-Heart 209:968-977. Sep. 2005.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8103343||May 3, 2007||Jan 24, 2012||Cardiac Pacemakers, Inc.||Automatic modulation of pacing timing intervals using beat to beat measures|
|US8290587||Mar 8, 2011||Oct 16, 2012||Cardiac Pacemakers, Inc.||Modulation of AV delay to control ventricular interval variability|
|US8463380||Jan 24, 2012||Jun 11, 2013||Cardiac Pacemakers, Inc.||Automatic adaptation of A-V delay and HR for heart failure using beat to beat measures|
|US8761879||Jun 11, 2013||Jun 24, 2014||Cardiac Pacemakers, Inc.||Automatic modulation of pacing timing intervals using beat to beat measures|
|US8886307||Jan 30, 2012||Nov 11, 2014||Medtronic, Inc.||Adaptive cardiac resynchronization therapy|
|US20080275520 *||May 3, 2007||Nov 6, 2008||Hopper Donald L||Automatic modulation of pacing timing intervals using beat to beat measures|
|US20110160789 *||Jun 30, 2011||Barun Maskara||Modulation of AV Delay to Control Ventricular Interval Variability|
|U.S. Classification||607/9, 607/119, 600/373, 600/374, 607/17, 600/513, 600/509|
|Cooperative Classification||A61N1/36542, A61N1/3627, A61N1/36564, A61N1/36585, A61N1/3682|
|Jul 25, 2007||AS||Assignment|
Owner name: MEDTRONIC, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PRAKASH, RAJAN;SAMBELASHVILI, ALEKSANDRE T.;REEL/FRAME:019608/0717
Effective date: 20070709
|Oct 20, 2014||FPAY||Fee payment|
Year of fee payment: 4